Does acupuncture enhance the pain relief of chronic temporomandibular pain dysfunction syndrome (TMPDS) when combined with a the usual standard regime of resting splints and physiotherapy
| ISRCTN | ISRCTN74414962 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN74414962 |
| Secondary identifying numbers | N0226132754 |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 26/04/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Mrs Christine McNeil
Scientific
Scientific
South Manchester University Hospitals NHS Trust
Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom
| Phone | +44 (0)161 336 7433 |
|---|---|
| johnchrismc@ukgateway.net |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | If the addition of acupuncture to established treatment regimes for TMPDS: 1. Enhances pain relief over the short and long term (1 year) 2. Improves patient satisfaction with treatment 3. Is a cost effective addition to treatment in the long term It also aims to quantify the reduction in medication use: a potential cost saving to the NHS |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Temporomandibular disorder (TMD) |
| Intervention | 1. Acupuncture combined with the usual standard regime of resting splints and physiotherapy 2. Usual standard regime of resting splints and physiotherapy alone |
| Intervention type | Other |
| Primary outcome measure | Pain relief |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 23/01/2003 |
| Completion date | 06/06/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 60 |
| Key inclusion criteria | 30 patients with facial pain of temporomandibular or myofacial origin from the referrals to the consultants at the Maxillofacial Clinic (Mr JR Tuffin, Mr M Patel and Mr K Sanders) and 30 controls (recruited using randomly generated numbers). |
| Key exclusion criteria | 1. Patients who have had surgery to the TMJ/head/neck or radiotherapy 2. Contradiction to the techniques: acupuncture/severe needle phobia, uncontrolled anti-coagulation/stainless steel allergy 3. Non-consenting patients 4. Unclear diagnosis 5. Dystonic facial muscles |
| Date of first enrolment | 23/01/2003 |
| Date of final enrolment | 06/06/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
South Manchester University Hospitals NHS Trust
Manchester
M23 9LT
United Kingdom
M23 9LT
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
South Manchester University Hospitals NHS Trust (UK)
No information available
NHS R&D Support Funding (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
